On November 9, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported the presentation of data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy in non-small cell lung cancer (NSCLC) at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Advaxis, NOV 9, 2020, View Source [SID1234570319]). ADXS-503 is the first drug construct from the Company’s ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.

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The data presented across three cohorts; Part A monotherapy, Part B combination with KEYTRUDA and Part C combination with KEYTRUDA in the first line setting for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy, together, demonstrate that ADXS-503 was safe and well tolerated, and may restore or enhance sensitivity to checkpoint inhibitors as an off-the-shelf, neoantigen immunotherapy.

"The results observed thus far in Part B of this study, with ADXS-503 added to KEYTRUDA without intervening treatment or a change in the checkpoint inhibitor at the time of progression on KEYTRUDA, provide encouraging proof-of-concept that ADXS-503 may re-sensitize or enhance the response to KEYTRUDA," said Jonathan W. Goldman, M.D., Department of Medicine, Ronald Regan UCLA Medical Center, UCLA Health Santa Monica Medical Center, and Lead Study Investigator. "The results in Part B also demonstrate an improved disease control rate compared to other checkpoint rechallenge studies. We are equally intrigued with the duration and quality of the clinical benefit, as four patients have been safely treated and done well with the combination therapy, two of them for more than 10 months as of today. Importantly, the immune correlative data support the thesis that ADXS-503 is synergizing well with KEYTRUDA by activating cytotoxic and memory CD8+ T cells. We are eagerly collecting additional data to better define the role of ADXS-503 and KEYTRUDA in this setting and in Part C of the study in first line therapy of NSCLC patients."

Key presentation highlights:

Poster presentation titled, "Phase 1/2 Study of an Off-the-Shelf, Multi-Neoantigen Vector (ADXS-503) Alone and in Combination with Pembrolizumab in Subjects with Metastatic Non-Small Cell Lung Cancer (NSCLC)" presented by Jonathan W. Goldman, M.D., Department of Medicine, Ronald Reagan UCLA Medical Center, UCLA Health Santa Monica Medical Center, and lead study investigator

ADXS-503 alone (Part A) and in combination with Pembrolizumab (Part B-DL1 and Part C) appeared safe and tolerable.
There were no added toxicities from combining ADXS-503 with Pembrolizumab
In Part A, ADXS-503 alone achieved stable disease in 50% (n=6) of heavily pre-treated patients including prior treatment with checkpoint inhibitors in all but one patient

In Part B, the overall response rate (17%) and disease control rate (67%) (n=6) suggest that adding on ADXS-503 after immediate prior progression on Pembrolizumab may re-sensitize or enhance response to Pembrolizumab

The first two patients treated in the Part B that had achieved SD and PR have now lasted 10 months

In Part B, one patient with squamous histology also achieved stable disease, suggesting this regimen may be broadly applicable across NSCLC

Biomarker data from 9 patients to date, 6 from Part A and 3 from Part B, show:

Activation of cytotoxic- and/or memory-CD8+ T cells in patients treated with monotherapy and in combination therapy
100% efficient priming by ADXS-503 with generation of CD8+ T cells against neoantigens in the vector as well as antigen spreading observed
Patients with known KRAS mutations in tumor samples have achieved stable disease in the study, including KRAS G12D in 2 out of 6 patients in Part A and KRAS G12V in 1 out of 3 in Part B DL1. Mutational analysis is ongoing across all patients.
Ken Berlin, Chief Executive Officer of Advaxis, said, "We are increasingly confident that ADXS-503, as an off-the-shelf neoantigen therapy, may be an important new approach to expand the benefit and durability of treatment with checkpoint inhibitors. These expanded biomarker data serve as in important proof-of-mechanism of ADXS-503 activity, stimulating both innate and adaptive immune responses with measured responses to neoantigens in our vector and antigen spreading observed. These encouraging efficacy and immune response data, in combination with a favorable safety and tolerability profile, suggest that our unique approach to neoantigen immunotherapy may be broadly applicable in lung cancer and potentially in other solid tumors. We look forward to increased momentum in the program as we continue to enroll patients in the Part B efficacy expansion and Part C expansion to the first line setting."

The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed. Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA is currently enrolling its efficacy expansion for up to 15 patients at dose level 1 (1 X108 CFU + KEYTRUDA) with the potential to proceed to dose level 2 (5 X108 CFU + KEYTRUDA) at a later date. Part C, which is evaluating ADXS-503 in combination with KEYTRUDA (1 X108 CFU + KEYTRUDA) as a first line treatment for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy is currently enrolling patients.

About ADXS-HOT
ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.

On November 9, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the third quarter ended September 30, 2020 and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Scholar Rock, NOV 9, 2020, View Source [SID1234570318]).

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"We achieved a significant milestone with the TOPAZ interim analysis proof-of-concept results. The data support apitegromab’s potential to improve motor function for patients with Type 2 and Type 3 SMA and importantly, highlight the therapeutic potential of our platform targeting the latent forms of growth factors, which includes SRK-181 in immuno-oncology," said Tony Kingsley, President and CEO of Scholar Rock. "As we look to the remainder of 2020 and into 2021, I am very excited for the potential of the company as we continue to advance and expand our pipeline across a wide range of serious diseases where growth factors may play a role, including other neuromuscular disorders, cancer, and fibrosis."

Company Updates and Upcoming Milestones

Apitegromab (SRK-015) Program for Spinal Muscular Atrophy (SMA):

Apitegromab is a highly selective inhibitor of latent myostatin activation being developed as the potential first muscle-directed therapy for the treatment of SMA.

Six-Month Interim Data from TOPAZ Demonstrate Meaningful Potential for Apitegromab to Improve Motor Function for Patients with SMA. In October 2020, Scholar Rock announced positive proof-of-concept data from a pre-planned six-month interim analysis of the TOPAZ Phase 2 trial, which enrolled 58 patients with Type 2 and Type 3 SMA across three parallel cohorts. Key findings included:
Treatment with apitegromab led to improvements in the Hammersmith scale scores (primary efficacy endpoint that measures motor function) in all three cohorts of patients with Type 2 and Type 3 SMA.
Substantial proportion of patients in each cohort attained ≥3-point improvement in Hammersmith scores.
Dose response in the primary efficacy endpoint was observed in the randomized, double-blind Cohort 3, with apitegromab high dose (20 mg/kg) attaining a 5.6 point mean improvement at six-months over baseline compared to low dose (2 mg/kg) attaining a 2.4 point mean improvement over baseline.
Pharmacokinetic and pharmacodynamic data supported the clinically observed dose response; apitegromab high dose (20 mg/kg) yielded higher levels of drug exposure and target engagement than low dose (2 mg/kg).
No safety signals were identified from the interim analysis. The five most frequently reported treatment-emergent adverse events (TEAEs) were headache, upper respiratory tract infection, pyrexia, nasopharyngitis, and cough.
Detailed interim analysis results from the TOPAZ trial were issued on October 27, 2020: Scholar Rock Announces Positive Proof-of-Concept Data from TOPAZ Phase 2 Trial Interim Analysis of SRK-015 in Patients with Type 2 and Type 3 Spinal Muscular Atrophy.
Top-line data for the 12-month treatment period are expected in the second quarter of 2021. Twelve-month results could provide additional insights on the potential durability of effect and the potential for further improvements in motor function, as well as additional safety data. There may be impacts on the timing of future doses and assessments for patients in the trial as the effects of the COVID-19 pandemic continue to evolve.

As of November 5, 2020, 45 of 45 patients who have completed the 12-month study have opted into the extension period.

Product candidate, SRK-015, now referred to as apitegromab. The United States Adopted Names (USAN) Council has approved the use of the non-proprietary name apitegromab for SRK-015, the Company’s product candidate for the treatment of patients with SMA. The USAN Council is responsible for selecting simple, informative and unique non-proprietary (generic) drug names and establishes logical nomenclature classifications based on pharmacological and/or chemical relationships. The council consists of a Food and Drug Administration (FDA) liaison, one member-at-large, and one representative from each of the following: The American Medical Association (AMA), United States Pharmacopeia (USP) and the American Pharmacists Association (APhA).
SRK-181 Program for Immuno-Oncology:

SRK-181 is a potent and highly selective inhibitor of latent TGFβ1 activation being developed towards an aim of overcoming resistance to and increasing the number of patients who may benefit from checkpoint inhibitor therapy.

Progress Update on Dose Escalation in Part A of the DRAGON Phase 1 Trial to be Presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. A poster presentation titled: "DRAGON: Phase 1 trial of SRK-181, a latent TGFβ1 inhibitor in combination with anti-PD-(L)1 inhibitors for patients with solid tumors unresponsive to anti-PD-(L)1 therapy alone," is being presented at the SITC (Free SITC Whitepaper) congress being held November 9-14, 2020. The poster outlines the dose escalation scheme and provides an update on progress of patient enrollment and advancement in dose levels. As of October 1, 2020, eight patients have been dosed in Part A1 of the trial, which evaluates SRK-181 as a monotherapy. No dose-limiting toxicities had been observed up to the 800 mg dose and the 1600 mg dose is currently under evaluation. Part A2 of the trial, which evaluates SRK-181 in combination with an approved anti-PD-(L)1 therapy, has enrolled two patients at the 240 mg dose as of October 1, 2020.

The two-part DRAGON Phase 1 clinical trial consists of a dose escalation portion (Part A) and a dose expansion portion (Part B) to evaluate SRK-181 in combination with an approved anti-PD-(L)1 therapy in patients with locally advanced or metastatic solid tumors exhibiting primary resistance to that anti-PD-(L)1 therapy. Part B will encompass multiple cohorts that are expected to include urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, and other solid tumors. Scholar Rock anticipates several updates from the DRAGON trial over the next year, including updates on dose escalation, an advancement to Part B that is expected in the first quarter of 2021, and clinical response and safety data in the second half of 2021. There may be impacts on the enrollment rate and dosing of patients in the trial as the effects of the COVID-19 pandemic continue to evolve.
Presentation of Preclinical TGFβ1 Data at the Festival of Biologics, World Immunotherapy Congress 2020. On November 5, 2020, Scholar Rock presented previously announced preclinical data at the virtual Festival of Biologics. The presentation titled: "Selective inhibition of TGFβ1 activation overcomes primary resistance to checkpoint inhibition therapy" detailed the potential of a potent and select inhibitor of latent TGFβ1 activation, such as SRK-181, in overcoming the dose-limiting toxicities associated with non-selective approaches to targeting TGFβ. In mouse tumor models that recapitulate key features of primary resistance to checkpoint inhibitor therapy, combination treatment with SRK-181-mIgG1 (murine version of SRK-181) and an anti-PD-1 therapy resulted in tumor regression or control and survival benefit.
Third Quarter 2020 Financial Results

For the quarter ended September 30, 2020, net loss was $23.6 million or $0.79 per share compared to a net loss of $16.1 million or $0.55 per share for the quarter ended September 30, 2019.

Revenue was $3.0 million for the quarter ended September 30, 2020 compared to $4.8 million for the quarter ended September 30, 2019. Revenue was related to the Gilead fibrosis-focused collaboration that was executed in December 2018.
Research and development expense was $18.4 million for the quarter ended September 30, 2020 compared to $15.7 million for the quarter ended September 30, 2019. The increase year-over-year is primarily attributable to costs associated with the apitegromab TOPAZ Phase 2 clinical trial, including clinical drug supply manufacturing, as well as higher personnel-related costs.
General and administrative expense was $8.3 million for the quarter ended September 30, 2020 compared to $6.2 million for the quarter ended September 30, 2019. The increase year-over-year was primarily attributable to higher personnel-related costs.
As of September 30, 2020, Scholar Rock had cash, cash equivalents, and marketable securities of $116.3 million. On October 19, 2020, Scholar Rock announced the closing of a $50 million debt facility, of which $25 million was funded at closing. On November 2, 2020, Scholar Rock announced the closing of a public offering of common stock and prefunded warrants and full exercise of the underwriters’ option to purchase additional shares of common stock. The aggregate gross proceeds to Scholar Rock from this offering were $230 million, before deducting underwriting discounts and commissions and other offering expenses.

"With the recent public offering and the addition of the debt facility, we have significantly strengthened our balance sheet and extended our cash runway into 2023," said Ted Myles, CFO and Head of Business Operations of Scholar Rock. "We are fully investing in our clinical product candidates, apitegromab and SRK-181, as well as our preclinical programs and the underlying scientific platform to develop important therapies for patients in need."

On November 9, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported updated interim results from the ongoing global, open-label, multicohort Phase 1 clinical trial of its anti-PD-L1 antibody, cosibelimab, in patients with advanced cancers, including a cohort of patients with previously untreated high PD-L1 expressing advanced non-small cell lung cancer ("NSCLC") (Press release, Checkpoint Therapeutics, NOV 9, 2020, View Source [SID1234570317]). The updated interim results are being presented in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting being held virtually from November 9-14, 2020.

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"The single-agent activity of cosibelimab in NSCLC is compelling, with the observed 44.0% objective response rate and 10.3-month median progression-free survival comparing favorably to the datasets generated in similar subjects from the PD-(L)1 therapies available today. Based on the strength of these results, we intend to initiate a Phase 3 registration-enabling trial evaluating cosibelimab in combination with chemotherapy in first-line, metastatic NSCLC patients," said James F. Oliviero, President and Chief Executive Officer of Checkpoint. "The annual market for PD-(L)1 therapies in NSCLC is approximately $10 billion and growing. If approved, we believe cosibelimab could capture meaningful market share as a lower-priced alternative to therapies currently available, and NSCLC is an ideal follow-on to our planned first indication of cutaneous squamous cell carcinoma, for which top-line results from an on-going registration-enabling trial are expected in the second half of 2021."

Summary of NSCLC Data Presented at SITC (Free SITC Whitepaper):
The ongoing trial is evaluating cosibelimab administered as a fixed dose of 800 mg every two weeks or 1200 mg every three weeks. The NSCLC cohort includes patients with Stage IV NSCLC with high (tumor proportion score ≥50%) PD-L1 tumor expression as determined by immunohistochemistry, with no prior systemic treatment for advanced/metastatic NSCLC and no epidermal growth factor receptor ("EGFR") activating mutation or anaplastic lymphoma kinase ("ALK") translocation.

As of the interim analysis, 25 patients with NSCLC were enrolled and evaluable for efficacy by investigator assessment with at least one post-baseline tumor assessment or discontinued treatment prior. Tumor response assessments are summarized in the table below.

Tumor Response by RECIST 1.1 NSCLC
(n=25)
Best overall response, n (%)
Complete response -
Partial response 11 (44.0)
Stable disease 8 (32.0)
Progressive disease 2 (8.0)
Not evaluated/done1 4 (16.0)
Objective response rate, % (95% CI) 44.0 (24.4, 65.1)
Response ongoing, n (%) 4 (36.4)
Median duration of response, months
(min, max) 15.3
(5.7, 20.5+)
Median progression-free survival, months
(95% confidence interval) 10.3
(7.0, 13.7)
Objective response rate = best overall response of complete response or partial response divided by the number of evaluable patients. 1Represents patients who discontinued study without a post-baseline tumor assessment.

At the time of analysis, 123 patients with advanced cancers had been treated with cosibelimab and were evaluable for safety. Cosibelimab appeared to be safe and well-tolerated with a potentially favorable safety profile as compared to anti-PD-1 therapies currently available. The most common treatment-related adverse events ("TRAEs") included fatigue (n=19, 15.4%) and rash (n=17, 13.8%), with only 2 patients (1.6%) discontinuing treatment due to a TRAE. Grade ≥3 TRAEs occurred in only 6 patients (4.9%), most commonly anemia and fatigue (each n=2, 1.6%, grade 3 only).

A copy of the poster presentation is available on the Publications page of the Pipeline section of Checkpoint’s website, www.checkpointtx.com.

Additional information on the meeting can be found on the SITC (Free SITC Whitepaper) website, www.sitcancer.org.

About Lung Cancer
According to the American Cancer Society, it is estimated that more than 228,000 Americans will be diagnosed with lung cancer in 2020, and non-small cell lung cancer accounts for 80-85% of all lung cancers. It is estimated that approximately 85% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.

About Cosibelimab
Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types.

On November 9, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that preclinical data on SRF388, a first in class IL-27 blocking antibody in clinical trials for patients with cancer, and SRF114, a CCR8-selective antibody, will be presented at the Society for Immunotherapy for Cancer’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, which will be held virtually on November 11–14, 2020 (Press release, Surface Oncology, NOV 9, 2020, View Source [SID1234570316]).

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"These data demonstrate single agent activity of SRF388 in a mouse model of hepatocellular carcinoma, or HCC, and identify candidate biomarkers associated with IL-27 blockade. Moreover, serum levels of the IL-27 subunit EBI3 were found to be elevated in many patients with HCC and associated with poor prognoses, highlighting the importance of this cytokine in a difficult to treat cancer," said Vito Palombella, chief scientific officer. "Compelling preclinical data for SRF114 will also be presented; these data demonstrate highly-selective CCR8 binding and depletion of tumor regulatory T cells. We are very encouraged by these data as we continue to advance both programs."

Summaries are provided below; full posters will be placed on Surface Oncology’s website following the start of the presentation.

Details of Surface’s SITC (Free SITC Whitepaper) presentations:

Session Title: Virtual Poster Hall Session
Presentation Title: Increased Serum Levels of EBI3 Are Associated with Poor Outcome in Hepatocellular Carcinoma Patients and SRF388, a First-in-Class IL-27 Blocking Antibody, Inhibits the Growth of Murine Liver Tumors
Lead Author: Matthew Rausch, Ph.D.
Session Date and Time: Wednesday, November 11, 2020, 9:00 a.m. ET

Summary:

•SRF388 is a monoclonal antibody designed to inhibit the immuno-suppressive cytokine IL-27.
•Circulating levels of the EBI3 subunit of IL-27 are elevated in a subset of patients with HCC and inversely correlated with overall survival.
•SRF388 enhances proinflammatory cytokine production in combination with PD-1 blockade in vitro in activated peripheral blood mononuclear cells from healthy donors and patients with HCC. Furthermore, SRF388 demonstrates single-agent activity in vivo in a murine orthotopic model of HCC.

Session Title: Virtual Poster Hall Session
Presentation Title: SRF114 is a Fully Human, CCR8-Selective IgG1 Antibody that Induces Destruction of Tumor Tregs Through ADCC
Lead Author: Andrew C. Lake, Ph.D.
Session Date and Time: Wednesday, November 11, 2020, 9:00 a.m. ET

Summary:

•Targeting CCR8 with SRF114 causes depletion of intra-tumoral Tregs, important regulators of peripheral immune tolerance, through ADCC.
•SRF114 is highly selective for CCR8; no off-target binding was identified following extensive screening.

About SRF388:

SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including hepatocellular and renal cell carcinoma, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.

About SRF114:

SRF114 is a monoclonal antibody targeting the chemokine receptor CCR8. SRF114 is a highly-specific antibody that drives the tumor-specific depletion of immuno-suppressive T regulatory cells.

On November 9, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, reported financial results for its quarter ended Sept. 30, 2020 and provided an update on recent business performance (Press release, Myriad Genetics, NOV 9, 2020, View Source [SID1234570315]).

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Financial Highlights:
Myriad Genetics delivered total revenue in the quarter of $145.2 million which declined 22% year-over-year but increased 56% sequentially as the company continued to recover from the impact of the COVID-19 pandemic.

° Total test volumes of 209,000 declined 12% year-over-year but increased 40% sequentially. Test volumes improved to 90% of pre-pandemic levels by the end of September compared to 75% of pre-pandemic levels at the end of June.

° GAAP gross margin was 69.6% and non-GAAP gross margin was 69.8%, improving 890 basis points sequentially due to higher test volumes which led to improved fixed cost absorption and cost management.

° Total operating expenses declined $16.1 million year-over-year to $113.4 million in the September 2020 quarter.

° GAAP operating income increased $28.7 million sequentially; non-GAAP operating income increased $30.2 million sequentially.

° Identified more than $40 million in annualized cost savings which will be implemented over the next nine months. These cost savings will be partially offset by up to $20 million in strategic marketing and technology investments focused on areas such as improving the end-to-end customer experience, new sales tools, expanding consumer access to on-line genetic insights, and targeted direct-to-consumer marketing.

° GAAP earnings per share (EPS) were ($0.20) and adjusted EPS were ($0.15). Adjusted net loss per share declined 48% sequentially.

° GAAP free cash flow in the quarter was ($59.3) million, negatively impacted by normal timing of annual incentive payments as well as a large tax payment. The company ended the quarter with $190.6 million in cash and equivalents, and $123.3 million available under its existing credit facility.

° Changed methodology for calculating adjusted EPS to tax affect the add back for amortization of intangible assets associated with acquisitions. In the September quarter, this negatively impacted adjusted earnings per share by ($0.05). Non-GAAP EPS amounts have been updated to reflect this change in prior periods.

° Recognized $1.4 million in payer recoupments in the September quarter and established a $2.2 million reserve for future refunds of payments made previously by insurance carriers.

Business Performance and Highlights

Women’s Health
The Myriad Women’s Health business — which serves women who are assessing their risk of hereditary cancer, and women who are pregnant or planning a family — recorded revenue of $55.7 million in the quarter and declined 34% year-over-year. Elective testing for hereditary cancer has been disproportionately impacted by the global pandemic due to delayed elective office visits. The prenatal business has significantly recovered with test volumes increasing 7% relative to the September quarter last year.

myRisk Hereditary Cancer
° myRisk Hereditary Cancer test volumes for the Women’s Health business declined 29% year-over-year but increased 100% relative to the June 2020 quarter.

Foresight
° Evidence Street, the technology assessment organization for the Blue Cross Blue Shield Association issued a favorable medical policy decision on expanded carrier screening that may lead to improved coverage for ethnic minorities. If members of the Blues network adopt this policy and provide coverage for expanded carrier screening, a higher percentage of claims for this payer group will be paid.

Prequel
° The American College of Obstetricians and Gynecologist recently issued new guidelines recommending prenatal testing for average risk patients. The new guidelines support expanded access to these services for more women as well as test coverage by insurance providers. To date, these guidelines have led to new medical policy guidelines from payers now covering average risk testing and expanding reimbursement opportunities for 40 million covered lives.

° Launched new AMPLIFY technology further increasing the accuracy of the Prequel noninvasive prenatal screening (NIPS) test which detects fetal aneuploidies such as Down syndrome. This proprietary Myriad technology allows more women to receive highly accurate test results and avoid invasive procedures regardless of body mass index (BMI), race, or ethnicity. Following the AMPLIFY launch, Prequel test volumes increased to record volume levels by the end of September.

Oncology
The Myriad Oncology business unit provides hereditary cancer testing for patients who have cancer, and products such as the EndoPredict breast cancer prognostic test, the Prolaris prostate cancer test, and companion diagnostic tests that work with corresponding drugs. The Oncology business delivered total revenue of $58.4 million, up 8% relative to revenue of $54.2 million in the September quarter of last year. The business also realized strong growth from companion diagnostics including meaningful revenue in the quarter from its proprietary myChoice CDx test.

myRisk Hereditary Cancer
° myRisk Hereditary Cancer test volumes for the Oncology business declined 18% year-over-year but increased 55% relative to the June 2020 quarter.

Prolaris
° Received a final local coverage determination (LCD) for Myriad’s Prolaris test which provides an assessment of prostate cancer aggressiveness. The determination made by Palmetto GBA and CGS Administrators, LLC, two of the administrative contractors for the Centers for Medicare & Medicaid Services, expands benefit entitlements for patients with unfavorable intermediate and high-risk prostate cancer. The final LCD becomes effective Dec. 6, 2020 and will provide payment on a meaningful proportion of tests that currently do not qualify for reimbursement.

BRACAnalysis CDx
° Saw significant increases in BRACAnalysis CDx test volume in Japan with total revenue from the country increasing 200% year-over-year to $7.5 million.

° Received Japanese regulatory approval for BRACAnalysis CDx as a companion diagnostic for the PARP inhibitor olaparib for use in pancreatic and prostate cancer.

EndoPredict
° The German Federal Joint Committee (G-BA) recently completed the method evaluation assessment for EndoPredict, extending availability of this second-generation biomarker test to all patients with statutory health insurance in Germany. The Committee supports the use of biomarkers, now including EndoPredict, to identify those patients who will likely benefit from chemotherapy treatment. Receipt of payment on EndoPredict claims in Germany is anticipated to begin in 2021.

Mental Health
Myriad’s Mental Health business — which consists of the GeneSight Psychotropic test that helps physicians understand how genetic alterations impact response to antidepressant and other psychotropic medications — saw revenue of $11.9 million in the quarter compared to $22.7 million in the same period last year. Mental Health revenue has been significantly impacted by the COVID-19 pandemic as care providers have moved from live to virtual office visits.

GeneSight
° Received a final LCD for pharmacogenomic (PGx) testing by Palmetto GBA and CGS Administrators, LLC that expands coverage to tests ordered by all healthcare providers licensed and qualified to diagnose associated conditions and prescribe relevant medications (either independently or in an arrangement).

° Broadened access to the GeneSight test among front-line providers of mental health treatment, including primary care physicians and nurse practitioners who treat the majority of depression and anxiety patients, through the expansion of sales and digital marketing capabilities.

Autoimmune
Myriad’s Autoimmune business — which consists of the Vectra test for measuring disease activity in rheumatoid arthritis — generated revenue of $9.1 million in the quarter compared to $11.0 million in the same period last year.

Vectra
° Launched a new enhancement to the Vectra test report providing an individualized estimate of a patient’s one-year risk of rapid radiographic progression (RP). The RP result in every report is personalized based on the patient’s age, gender and body mass. The new data will help physicians more accurately assess risk for disease progression.

Other
Other revenue – comprised of Myriad RBM contract research services for the pharmaceutical industry and the myPath Melanoma diagnostic test in dermatology — was $10.1 million in the September quarter versus $14.5 million in the same period in the prior year. The decline in revenue is attributable to the previously announced sale of Myriad’s German clinic which occurred at the beginning of calendar year 2020.

° Announced the decision to pursue strategic alternatives for the Myriad RBM and Dermatology business units as part of the company’s transformation and growth plan.

Corporate Governance Changes
With the filing of its proxy statement in October, Myriad announced multiple corporate governance changes to better serve key stakeholders including a refreshment process for its Board of Directors, management objectives and compensation updates based on financial performance, and the move from a June 30 fiscal year to a calendar year end.

Financial Guidance
Given the continued unpredictability surrounding the COVID-19 pandemic and the impact it has had on the healthcare environment, customer behavior and the ability to market tests to physicians, the company will not provide financial guidance for the six-month transition period ending Dec. 31, 2020.

Conference Call and Webcast
A conference call will be held today, Monday, Nov. 9, 2020, at 5 p.m. EST to discuss Myriad’s financial results for the September quarter and business developments. The dial-in number for domestic callers is 1-800-760-5095. International callers may dial 1-212-231-2937. All callers will be asked to reference reservation number 21970797. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call along with a slide presentation will be available through a live webcast at www.myriad.com.